Sensor delivery system and method

ABSTRACT

Provided are various embodiments of improvements made to methods, systems and assemblies of implant delivery systems and the associated implants. In one embodiment, provided is an implant delivery system comprising an implant, a first sheath and a second sheath each extending from a proximal end of said implant delivery system, the first sheath is translatable relative to said second sheath wherein said implant is connected to an exterior surface of said first sheath, and wherein said first sheath and said second sheath are movable with respect to one another to deploy said implant to a target site in an anatomy. Said delivery system may be configured to be partially inserted into a blood vessel of a human body such that said proximal end remains external to said body and said distal end is internal to said body.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent App. No.62/784,887 entitled “SENSOR DELIVERY SYSTEM AND METHOD” and filed Dec.26, 2018. This application is a continuation-in-part of U.S. patentapplication Ser. No. 16/243,183 entitled “PRESSURE SENSOR, ANCHOR,DELIVERY SYSTEM AND METHOD and filed Jan. 9, 2019 which claims priorityto U.S. Pat. No. 10,206,592 entitled “PRESSURE SENSOR, ANCHOR, DELIVERYSYSTEM AND METHOD and filed Mar. 16, 2015 which claims priority to PCTPatent App. No. PCT/US2013/059769 entitled “PRESSURE SENSOR, ANCHOR,DELIVERY SYSTEM AND METHOD and filed on Sep. 13, 2013, that claimspriority to U.S. Provisional Patent App. No. 61/701,058 entitled“PRESSURE SENSOR, ANCHOR, DELIVERY SYSTEM AND METHOD” and filed on Sep.14, 2012, and further claims priority to PCT Patent App. No.PCT/US2011/045583 entitled “PRESSURE SENSOR, CENTERING ANCHOR, DELIVERYSYSTEM AND METHOD” and filed on Jul. 27, 2011. This application is alsoa continuation-in-part of U.S. patent application Ser. No. 15/213,712entitled “PRESSURE SENSING IMPLANT,” filed on Jul. 19, 2016 which is acontinuation-in-part of U.S. patent application Ser. No. 14/777,654entitled “PRESSURE SENSING IMPLANT” filed on Sep. 16, 2015 each of whichare incorporated by reference.

FIELD OF INVENTION

This application relates to a medical implantable devices, positioningand anchoring mechanisms, delivery systems and more particularly to amethod for delivering and positioning medical implantable devices intothe human body.

BACKGROUND

Delivery systems and positioning and anchoring devices are currentlybeing used in medical procedures to guide and position devices from aremote site to a target site within a body. Catheter-based deliverysystems are generally used to guide and position invasive implantables,such as pressure sensors, within the cardiovascular system of a patient.There exist various commercial implantable pressure sensors that arepermanently implanted within the cardiovascular system usingcatheter-based delivery systems. One example is the CardioMEMS device byAbbott Labs, Inc. References: “CardioMEMS HF System, PA Sensor andDelivery System”, St Jude Medical Publication US-2000054 B EN (06/14);Shavelle, D, MD; Jermyn, R, MD; “The CardioMEMS Heart Failure Sensor: AProcedural Guide for Implanting Physicians”, Journal of InvasiveCardiology 2016; 28(7):273-279.; “CardioMEMS HF System, PA Sensor andDelivery System, Model CM2000, User's Manual”, CardioMEMS publicationLA-400275-03, Art 60056412, May 2014; “CardioMEMS Implant Procedure andPatient Training Video” St Jude Medical video SJM-MEM-0215-0085a. 2015.

FIG. 1 illustrates a schematic diagram of a prior art catheter-baseddelivery system disclosed by the described publications that describes amethod for implanting a pressure sensor implant within the pulmonaryartery of a patient using a pulmonary artery catheter (“PAC”). Here, thePAC includes a catheter having an inflatable balloon along a distal endof an elongated tube structure. The PAC is configured to provide fluidcommunication from a target site to the proximal end of the catheteroutside the body. The PAC allows for pressure measurements as well asdrug injections. It may also have other features, such as ability tomeasure cardiac output using the well-known thermodilution method. In aknown embodiment, the target site includes the pulmonary artery but maybe any other location within a patient's anatomy, preferably within thecardiovascular system.

The steps disclosed by this procedure include the following asillustrated by FIG. 1. Venous access may be established at an accesslocation along the patient's anatomy by puncturing a vein percutaneously(1). This may also include inserting an “introducer” at the accesslocation to support the insertion of various catheters. The femoral veinis a typical access location; jugular, brachial, and subclavian vein arealso known access locations. The distal end of a first pulmonary arterycatheter (“PAC”) is then inserted at the access location (2). A balloonmay be inflated along a distal portion or distal top of the PAC withinthe vascularity of the patient (3). The inflated balloon may be used tofree up blocked vessels or temporarily block blood flow to a certainbranch. It may also be used to float the PAC along with the bloodstreamtowards the target anatomy. The target site may be anything in the pathof venous flow, including any of the veins, the heart, the pulmonaryartery, or even inside the gastrointestinal (GI) tract. The PAC may alsobe configured to take pressure readings or measure output (viathermodilution) along its journey through the anatomy up to andincluding the target site. Thermodilution is a method of measuring bloodflow based on the premise that when an indicator substance is added tocirculating blood, the rate of blood flow is inversely proportional tothe indicator concentration change over time. The measurements taken ofthe target site, for example, could include but is not limited to theright atrial pressure, right ventricular pressure, pulmonary arterypressure, and pulmonary artery wedge pressure.

Contrast dye may be injected through a port in the PAC to assist withimaging and examining the anatomy with a fluoroscope (4). The contrastdye may be injected into the anatomy by introducing the contrast dyethrough the proximal end of the PAC outside the body, to be dispensednear the distal end of the PAC within the body. Imaging display may thenclearly illustrate the vasculature with the contrast dye. This processis called angiography and the image you get from it is an angiogram.Prior art systems utilize static photos/freeze-frames of the angiogramto assist with positioning the sensor or implant with a second catheteras described below.

Preferably, during this procedure, the distal end of the PAC may belocated at or near the target site and a guide wire (GW) may be insertedor positioned within a lumen of the PAC (5). The guide wire (GW) mayslide or otherwise be withdrawn from a lumen within the PAC to bepositioned at or adjacent the target site (6). The PAC may be removedallowing the guide wire (GW) to remain positioned therein. The guidewire (GW) may remain located within the vasculature between the accesslocation and the target site to guide other catheters in and out to thetarget site (7).

A delivery catheter (DC) including a sensor or implant attached at ornear a distal end thereto may be inserted through the access location ofthe patient with the assistance of the guide wire (GW) to position thesensor or implant towards the target site. The fluoroscope may visuallyassist the medical practitioner to monitor the anatomy as the sensor orimplant is positioned at or near the target site. The sensor may includefluoro markers to allow the visual assistance of the sensor or implanton the fluoroscope as well as guide wire (GW). However, at this point inthe procedure of known delivery systems, contrast dye is not availableand live images of the position of the sensor/implant along the DCrelative to the vasculature is therefore not available (8). The medicalpractitioner must utilized the angiogram image acquired when contrastdye was introduced by the PAC moments ago to compare the relativeposition of the DC and sensor relative to anatomical markers (e.g.,ribs, pacemaker, spine). This comparison of step (8) allows the medicalpractitioner to estimate sizes and locations using known featuresavailable from a static image of the angiogram in the estimation ofplacing the sensor or implant at the target site in the anatomy.

This requires the medical practitioner in control of the deliverycatheter to stop and hold its position as the comparison occurs betweenthe live fluoroscopic image (of the sensor) with the static angiogram“map” made moments ago. Steps (9) and (10) reflect the continualiterative process of moving or adjusting the delivery catheter andcomparing the angiogram “map” with the live fluoro image until themedical practitioner in control of the deliver catheter estimates thatthe sensor or implant is positioned at the “estimated” target site. Oncereached, the sensor or implant is deployed at the estimated target site(11). This may occur by triggering a mechanism at the proximal end ofthe delivery catheter that actuates release wires attached to the sensoror implant to release the senor or implant therefrom. The sensor is nowdeployed and the delivery catheter is removed from the patient (12) asthe guide wire remains therein.

A second calibration catheter (“CC”), similar in type to the firstpulmonary artery catheter PAC, may be inserted at access location alongthe guide wire (13). The second calibration catheter CC may include afluid lumen therein but may not include a distally positioned balloon.Notably, each of these types of catheters are designed for a single useand may be costly. The fluid lumen may extend along the length of thesecond catheter CC and couple the proximal end to a second sensor. Thesecond sensor may be an off-the-shelf one-use pressure sensor ortransducer device that is used to obtain a reference reading (14). Thesecond sensor may be placed at or near the target site that includes thesensor or implant for taking the reference reading. That referencereading may be used to adjust, correct, or otherwise calibrate thesensor or implant as it is placed at the target site. This is “in situcalibration” of the implanted sensor may be performed mathematically insoftware. The second catheter CC and guide wire GW may be removed (15)and the access location or vessel site may be closed (16).

Even though such implant procedures are minimally invasive and have agood safety record, any surgical procedure causes risk to the patient.There is a desire to minimize the time a patient is under anesthesia andexposed to risk of infection, also to minimize procedure time, use ofmedical resources, like a catheterization lab and implanting surgicalteams. There is also a desire to reduce cost of healthcare by minimizingthe amount of disposable and non-disposable equipment required for agiven procedure. There is a need to improve the simplicity andefficiency of similar systems and methods for convenience of the medicalpractitioners and to enhance patient safety.

SUMMARY

Provided are various embodiments of improvements made to methods,systems and assemblies of implant delivery systems and the associatedimplants. In one embodiment, provided is an implant delivery systemcomprising an implant, a first sheath and a second sheath each extendingfrom a proximal end of said implant delivery system, wherein at leastsaid first sheath extends to a distal end of said implant deliverysystem, wherein said first sheath is positioned at least partiallywithin said second sheath, the first sheath is translatable relative tosaid second sheath wherein said implant is connected to an exteriorsurface of said first sheath, and wherein said first sheath and saidsecond sheath are movable with respect to one another to deploy saidimplant to a target site in an anatomy. Said delivery system may beconfigured to be partially inserted into a blood vessel of a human bodysuch that said proximal end remains external to said body and saiddistal end is internal to said body. At least one fluid port may bepositioned along a proximal end of said first sheath or second sheath,said fluid port fluidly coupled to a lumen extending down the length ofsaid first sheath or second sheath to allow fluid flow through saidlumen. Fluid may be injected through said port and may includes one of:a drug; a fluid used to enhance anatomical imaging; fluoroscopiccontrast dye; barium; a radioactive material; blood; plasma; salinesolution; a blood component; a particle suspension; a nano-device; and ananomaterial. The at least one fluid port may further be configured tooperatively couple to a device located outside of said body wherein saiddevice is a pressure transducer, configured to measure a fluid pressureat the distal end of said first or said second sheath. Said measurementof fluid pressure at the distal end of said first or second sheath maybe used to calibrate or assess the accuracy of said implant.

At least one marker may be placed on the delivery system that isconfigured to be visible with a fluoroscope. Said marker may include aradio opaque material positioned on at least one of: a distal tip ofsaid first sheath; the distal portion of said second sheath; a portionof said implant; and as a plurality of lines spaced along a portion ofsaid first or said second sheath. The marker may be attached to at leastone anchor on the implant. A plurality of markers may be positionedalong said implant in an asymmetric pattern, said pattern is configuredto facilitate determination of implant orientation when viewed on afluoroscope. Said asymmetric pattern comprises markers at three of thefour corners of a two-dimensional rectangle when viewed normal to theplane of said rectangle on a fluoroscope.

Said fluid port may be further configured to allow removal of fluid fromsaid body. A balloon member may be positioned along the delivery system,wherein said balloon member is configured to be inflated to guide saiddeliver system to a target site. Said balloon member may be configuredto facilitate a wedge pressure measurement. Said balloon member may beconfigured to limit blood flow in a vessel to facilitate implantdeployment or retraction. Said balloon member may be configured to holdsaid first sheath in place with respect to a blood vessel while saidimplant is released from said first sheath at said target site. Atemperature sensor may be placed on said distal end to facilitatemeasurement of flow rate by thermodilution, wherein said flow ratemeasurement is configured to determine a cardiac output.

Said second sheath may be configured to allow insertion of a catheterdevice, wherein said catheter device includes at least one of: a camera,a pressure sensing catheter, a stent placement device, a valve placementdevice, a microphone, an ablation device, a balloon device, a Swan Ganzcatheter, an electrical stimulation device, an ultrasound device, a drugdelivery device, a catheter for gripping implanted devices, a catheterfor readjusting the position of implanted devices, a catheter forremoving implanted devices. Said second sheath may be configured toallow insertion of a catheter device configured to selectively attach tosaid implant and move the implant proximally when retracted, wherein atleast one anchor of said implant is collapsible, and wherein said anchorof said implant is configured to be placed in a collapsed state whensaid catheter device moves the implant proximally into said secondsheath. Said second sheath may be further configured to allow said firstsheath to be retracted into said second sheath while said implant isstill connected to said first sheath, and further configured to coversaid first sheath and said implant while said delivery system isretracted and withdrawn from said body. At least one release wire mayextend from said proximal end of said first sheath to said distal end,wherein said release wire is configured to connect said implant to saidfirst sheath. Said implant may be provided with at least one collapsibleanchor, and further wherein said at least one release wire connects saidimplant to said first sheath by exiting at least one slot positionedalong said first sheath, crossing over said anchor in said collapsedstate, and entering the at least one slot or a second slot along saidfirst sheath. Retraction of said at least one wire proximally may causesaid implant to be released from said first sheath.

A reference sensor may be positioned along the first sheath or thesecond sheath, wherein the reference sensor is independent of saidimplant. Said reference sensor may be at least one of a: pressuresensor, a blood oxygen level sensor, a microphone, a sensor of tissueoptical properties, a temperature sensor, a flow rate sensor, and achemical sensor. Said system may be configured to allow a user tomechanically couple or decouple said first sheath and said secondsheath, such that said sheaths can be made movable or non-movable withrespect to one another during use. Said first sheath may be configuredwith a distal tip made of a soft material to minimize vessel traumaduring use, wherein said distal tip has a durometer softer than Shore40A.

In another embodiment, provided is a method for implanting an implantdevice in the vasculature of a human body, said method comprising thesteps of: establishing access to the vasculature at an access locationalong the patient's anatomy; inserting a first catheter configured totranslate from the access location to a target site within thevasculature; placing a guide wire between said access point to saidtarget location; removing said first catheter while leaving said guidewire in place; inserting a delivery system over said guide wire, saiddelivery system comprising a first sheath and a second sheath eachextending from a proximal end of said implant delivery system, whereinat least said first sheath extends to a distal end of said implantdelivery system and wherein said first sheath is positioned at leastpartially within said second sheath, and includes an implant attached tosaid first sheath, wherein said first sheath or second sheath configuredto allow the injection of contrast dye for angiographic imaging;advancing said delivery system to said target site while usingangiographic imaging to position said implant at said target site;deploying said implant from said delivery system at said target site;and withdrawing said second catheter and said guidewire from said bodywhile said medical device remains at said target location. Said deliverysystem may include a port configured to fluidically couple a portion ofsaid first sheath or second sheath that is inside said vasculature to aportion of said first sheath or second sheath that is outside of saidvasculature, said method further comprising the steps of: connectingsaid outside portion of said first sheath or second sheath to a pressuremeasurement device; measuring pressure at said inside portion of saidfirst sheath or second sheath using said pressure measurement device;measuring pressure at said inside portion with said implant; comparingsaid measurement from said pressure measurement device to a measurementmade by said implant. The method may further comprise the steps ofassessing an accuracy of said implant and calibrating said implant.

Said port may be configured to inject contrast dye within thevasculature. Said implant may be connected to an exterior surface ofsaid first sheath and positioned near a distal end of said secondsheath, and wherein said first sheath and said second sheath are movablewith respect to one another to deploy said implant to the target site.Said first catheter device comprises one of a balloon member configuredto follow vascular flow to translate from said access location to saidtarget site and a steerable tip catheter.

Also provided is a method for implanting an implant in a vasculature ofa body, said method comprising the steps of: establishing access to thevasculature at an access location; inserting a catheter device into saidvasculature at said access location, said catheter device fitted withsaid implant and configured to advance to a target site; advancing saidcatheter device to said target site; deploying said implant from saidcatheter device at said target site; and withdrawing said catheterdevice from said body while said implant remains at said target site.Said catheter device may be configured to advance to said target site bya balloon member configured to follow vascular flow to translate fromsaid access location to said target site and a steerable tip catheter.Said catheter device may be configured to inject contrast dye into saidvasculature to facilitate angiographic imaging, said method furthercomprising the step of advancing said catheter to said target locationwhile using angiographic imaging. Said catheter device may be configuredto fluidically couple a portion of said catheter device inside saidvasculature to a portion of said catheter device that is outside of saidvasculature, said method further comprising the steps of: connectingsaid of said catheter device that is outside of said vasculature to apressure measurement device; before withdrawing said catheter devicefrom said body, measuring pressure at said portion of said catheterdevice inside said vasculature using said pressure measurement device;measuring pressure using said implant; comparing said measurement fromsaid pressure measurement device to a measurement made by said implant.

Said catheter device comprises a first sheath and a second sheath eachextending from a proximal end of said catheter device, wherein at leastsaid first sheath extends to a distal end of said implant deliverysystem, wherein said first sheath is positioned at least partiallywithin said second sheath; wherein said implant is connected to anexterior surface of said first sheath and positioned near a distal endof said second sheath, and wherein said first sheath and said secondsheath are movable with respect to one another to deploy said implant toa desired target location.

Also provided is an implant delivery system comprising: an implant; afirst sheath and a second sheath each extending from a proximal end ofsaid implant delivery system, wherein at least said first sheath extendsto a distal end of said implant delivery system, wherein said firstsheath is positioned at least partially within said second sheath;wherein said implant is connected to an exterior surface of said firstsheath and positioned near a distal end of said second sheath; andwherein said first sheath and second sheath are movable with respect toone another to deploy said implant to a desired location. Said implantfurther comprises a rigid housing, and at least one collapsible implantanchor, said at least one anchor being attached to said housing. Saidanchor may be comprised of at least one wire that passes through atleast one hole that extends through the thickness of said housing; andan enlarged portion of the wire is placed along said wire to retain thewire within the hole. Said hole may be counter-bored, said counter-boredhole comprising a first size hole and a second size hole, wherein thefirst size is smaller than the second size, wherein the second holeextends only partially through said housing, and further wherein saidenlarged portion is configured to fit into said second hole. Each end ofsaid anchors may be attached through a hole in said housing, such thatsaid anchor forms a partial or complete loop including two ends thatterminate at points on said housing. Said implant includes a markerconfigured to be at least partially visible under fluoroscopic imaging.Said marker may be positioned within said hole and includes a radioopaque material. Said anchor wire includes a nitinol material with aplatinum core. Said marker may be a radio opaque marker that includesone of a: paint, ink, or preformed cylindrical tube. The marker may be atube attached to said anchor wire by one of: adhesive, heat shrinking,and friction fit. A plurality of said markers may be spaced at knownintervals along said anchor wire or said catheter device to facilitatedistance estimation during angiographic imaging. Said marker may belocated on the anchor wire near a point where said anchor wire attachesto said housing. Said hole may be filled with a filler material toprevent rotational or translational movement of said anchor relative tosaid hole, wherein said filler material is selected from: adhesive,potting material, epoxy, silicone, or polymer. A plurality of saidmarkers comprise an asymmetric pattern on said implant body, saidpattern configured to facilitate determination of implant orientationwhen viewed on a fluoroscope. Said asymmetric pattern comprises threemarks positioned along three corners of a two-dimensional rectangle whenviewed on a fluoroscope.

Further, provided is a method for attaching a wire anchor to a rigidimplant body, comprising the steps of: providing at least one hole thatextends through an implant housing; passing an anchor wire through saidhole; enlarging at least one portion along said wire to prevent saidenlarged portion from passing through said hole. Said hole may be formedby counter-boring to create a large portion and a small portion. Saidenlarged portion of said wire may be placed into said large portion ofsaid hole. At least one preformed fluoroscopic marker may be placed oversaid anchor wire prior to enlarging said dimension of said terminal end.Two ends of said wire anchor may be attached to said implant body suchthat said anchor forms a loop. Said hole may be filled with a fillermaterial to event translational or rotational movement of said anchor.

DESCRIPTION OF THE DRAWINGS

These, as well as other objects and advantages of this application, willbe more completely understood and appreciated by referring to thefollowing more detailed description of the presently preferred exemplaryembodiments of the application in conjunction with the accompanyingdrawings, of which:

FIG. 1 illustrates the schematic diagram of a prior art procedure fordeploying a sensor to target site within a patient's anatomy;

FIG. 2 illustrates an embodiment of an implant attached to a deliverysystem according to aspects of the instant application;

FIG. 3 illustrates the schematic diagram of an embodiment of a methodand system according to aspects of the instant application for deployinga sensor to target site within a patient's anatomy;

FIG. 4 illustrates the schematic diagram of another embodiment of amethod and system according to aspects of the instant application fordeploying a sensor to a target site within a patient's anatomy;

FIG. 5 illustrates the schematic diagram of another embodiment of amethod and system according to aspects of the instant application fordeploying a sensor to a target site within a patient's anatomy;

FIG. 6A illustrates an embodiment of an implant from FIG. 22 of commonlyowned U.S. Pat. No. 10,206,592;

FIG. 6B is a cross sectional view of attachment portions of an implantaccording to aspects of the instant application;

FIG. 7A is a cross sectional view of a similar implant to FIG. 6B thatincludes an anchor wire as it is being assembled to the implantaccording to according to aspects of the instant application;

FIG. 7B is a cross sectional view of an embodiment of the implant ofFIG. 7A that includes the anchor wire with a marker band as it is beingassembled to the implant according to according to aspects of theinstant application;

FIG. 7C is a cross sectional view of an embodiment of the implant ofFIG. 7A that includes the anchor wire with the marker band as it isbeing assembled to the implant according to according to aspects of theinstant application;

FIG. 7D is a cross sectional view of an embodiment of the implant ofFIG. 7A with the anchor wire and marker band as it is being assembled tothe implant according to according to aspects of the instantapplication;

FIG. 7E is a cross sectional view of an embodiment of the implant ofFIG. 7A with the anchor wire and marker band assembled to the implantaccording to according to aspects of the instant application;

FIG. 8A illustrates a schematic plan view of an embodiment of theimplant that includes marker band locations according to aspects of theinstant application;

FIG. 8B illustrates a schematic plan view of an embodiment of theimplant that includes marker band locations according to aspects of theinstant application;

FIG. 8C illustrates a schematic plan view of an embodiment of theimplant that includes marker band locations according to aspects of theinstant application;

FIG. 9 is a cross sectional schematic view of an implant attached to adelivery system according to aspects of the instant application; and

FIG. 10 illustrates an embodiment of an implant attached to a retrievalsystem according to aspects of the instant application.

DETAILED DESCRIPTION

Reference will now be made in detail to exemplary embodiments of thepresent teachings, examples of which are illustrated in the accompanyingdrawings. It is to be understood that other embodiments may be utilizedand structural and functional changes may be made without departing fromthe respective scope of the present teachings. Moreover, features of thevarious embodiments may be combined or altered without departing fromthe scope of the present teachings. As such, the following descriptionis presented by way of illustration only and should not limit in any waythe various alternatives and modifications that may be made to theillustrated embodiments and still be within the spirit and scope of thepresent teachings. In this disclosure, any identification of specificshapes, materials, techniques, arrangements, etc. are either related toa specific example presented or are merely a general description of sucha shape, material, technique, arrangement, etc.

The instant application is directed to a method and system of utilizinga version of the delivery device similar to that disclosed by U.S. Pat.No. 10,206,592 of which this claims priority from. Referring now to theFigures, wherein common elements are identified by the same numbers,FIG. 2 illustrates a perspective view of a portion of such an improveddelivery device and system 200. The instant application discloses acatheter that includes a first or inner/carrier sheath 202 with a distaltip 201 and a second or outer/torque sheath 204 that extends proximallytherefrom. The sheaths include one or more lumens that extend therein toperform a variety of functions including but not limited to: support aguide wire, allow for fluid passage, support release wires, and inflateor deflate a balloon positioned along the length of the delivery device.The first and second sheaths 202, 204 may be elongated and be attachedat a proximal end to a handle (not shown) to allow for the control ofrotation and translation relative to one another. The carrier sheath 202and torque sheath 204 may be temporarily fixed to each other such thatfixed rotation and translation occurs when desired, but when notdesired, carrier sheath 202 and torque sheath 204 may move relative toone another.

One or more anchor release wires 212 may extend within lumens within thesheaths 202, 204. The wires 212 may extend from a proximal end of thecatheter towards the distal end and are configured to temporarilysupport and attach an implant 101 to the carrier sheath 202. Thisattachment may be established by engagement of anchors that extend fromthe implant 101. In one embodiment, the implant may be a wireless deviceconfigured to electronically communicate with a receiver or externalreader device. The implant may include an LC resonant tank within ahousing. In another embodiment, the implant may be a passive device oran active device and include a battery or other power source. Theanchors may include a distal anchor 103 and proximal anchor 102 thatextend from opposing portions of the implant 101. The anchor releasewires 212 attach to the carrier sheath 202 and anchor 102, 103 byentering into and out of one or more slots 215 positioned along thecarrier sheath 202. This arrangement may allow the anchors to becollapsed during implantation and to expand (e.g., FIG. 6A) once therelease wires 212 have been removed.

The carrier sheath 202 may be configured to rotate and to translate withthe torque sheath 204 or may be able to rotate and translate relative tothe torque sheath 204. This allows the sheaths to move proximal/distalrelative to one another or to prevent rotation of one sheath relative tothe other. Further, the distal tip 201 as well as desired portions alongthe sheaths 202, 204 may be covered with radio opaque material toimprove visibility during fluoroscopy. Likewise a ruled set of radioopaque markers 205 may be placed along a portion of the sheaths 202, 204having pre-defined separation distances. These markers 205 may assistwith establishing visible cues to assist the medical personnel withplacement of the delivery system 200 within the anatomy.

The outer sheath 204 may carry out various functions that are differentfrom prior versions of known systems. These functions include (a)injection of contrast dye for real-time angiography at any time when theouter sheath 204 is in the body; (b) use the outer sheath as the fluidcolumn (aka ‘fluid channel’ aka ‘lumen’) that fluidically couples thedistal end of the outer sheath to a proximal port 230, positionedoutside the patient's body, (c) a pressure transducer (not shown) may befluidically attached to the proximal port for procuring referencemeasurements, and (d) a reference sensor 210 may be attached to a distalportion of the outer sheath 204 for procuring reference measurements.Additionally, a balloon member 220 may optionally be positioned alongthe length of the inner sheath 202 or outer sheath 204 which may betoggled to inflate or deflate to assist with guiding the delivery devicewithin the vasculature as described below. Said balloon member may beconfigured to be inflated to guide said deliver system to the targetsite. Further, said balloon member may be configured to facilitate awedge pressure measurement. Said balloon member may also be configuredto limit blood flow in a vessel to facilitate implant deploymentretraction, or rotation while it may also be configured to hold saidfirst sheath in place with respect to a blood vessel while said implantis released from said first sheath at said target site. Said fluid portmay be configured to allow removal of fluid from said body. At least onetemperature sensor may be positioned on said distal end/tip 201 tofacilitate measurement of flow rate by thermodilution, wherein said flowrate measurement is configured to determine a cardiac output. Saidsecond sheath may be configured to allow insertion of a catheter device,wherein said catheter device includes at least one of: a camera, apressure sensing catheter, a stent placement device, a valve placementdevice, a microphone, an ablation device, a balloon device, a Swan Ganzcatheter, an electrical stimulation device, an ultrasound device, a drugdelivery device, a catheter for gripping implanted devices, a catheterfor readjusting the position of implanted devices, a catheter forremoving implanted devices.

FIG. 3 illustrates a schematic diagram of an embodiment of a method andsystem according to aspects of the instant application for deploying asensor or implant to a target site within a patient's anatomy. Thisdisclosure contemplates the use of the delivery system 200 forsurgically implanting the implant 101 or sensor within the vascularityof a patient to communicate with a reader device (not shown). Variousembodiments of the implant/sensor and reader device are contemplated bythe following commonly owned patent documents: U.S. patent applicationSer. No. 15/958,613 entitled “ANCHORING SYSTEM FOR A CATHETER DELIVEREDDEVICE,” filed on Apr. 20, 2018; U.S. patent application Ser. No.15/213,712 entitled “PRESSURE SENSING IMPLANT,” filed on Jul. 19, 2016;U.S. patent application Ser. No. 14/777,654 entitled “PRESSURE SENSINGIMPLANT” filed on Sep. 16, 2015; U.S. Pat. No. 8,493,187 entitled“WIRELESS SENSOR READER” filed on Mar. 19, 2010; U.S. Pat. No. 8,899,582entitled “CARDIAC PRESSURE MONITORING DEVICE” filed on Jan. 25, 2008;PCT Patent App. No. PCT/US2012/044998 entitled “IMPLANTABLE SENSORENCLOSURE WITH THIN SIDEWALLS” filed on Jun. 29, 2012, PCT Patent App.No. PCT/US2011/045581 entitled TRANSVASCULAR WIRELESS SENSOR SYSTEM”filed on Jul. 27, 2011; U.S. patent application Ser. No. 15/958,613entitled “ANCHORING SYSTEM FOR A CATHETER DELIVERED DEVICE,” filed onApr. 20, 2018; U.S. Provisional Application No. 62/624,146 entitled“DEVICE AND METHOD FOR DEPLOYING AND SECURING AN IMPLANT TO A VESSELWALL,” filed on Jan. 31, 2018, each of which are incorporated byreference. However, this application is not limited to the use withthese devices or assemblies as others may be contemplated.

Steps 10, 20 and 30 are comparable to steps (1), (2) and (3) of FIG. 1.Venous access may be established at an access location along thepatient's anatomy by puncturing a vein percutaneously 10. This may alsoinclude inserting an “introducer” at the access location to support theinsertion of various catheters. The femoral vein is a typical accesslocation; jugular, brachial, and subclavian vein are also known accesslocations. The distal end of a first pulmonary artery catheter (“PAC”)is then inserted at the access location 20. A balloon may be inflatedalong a distal portion or distal top of the PAC within the vascularityof the patient 30.

Notably, step (4) of FIG. 1 is not necessary for the process of FIG. 3,this is because a contrast map for future use is not appropriate as theanatomy is to be mapped in real time when the implant 101 is near thetarget site. Here, the PAC includes thee balloon function, so anyballoon catheter that can get you to the target site is acceptable—itdoes not need the additional contrast dye function.

Steps 40, 50, and 60, are similar to steps (5), (6), and (7) of FIG. 1.Here, the distal end of the PAC may be located at or near the targetsite and a guide wire (GW) may be inserted or positioned within a lumenof the PAC 40. The guide wire (GW) may slide or otherwise be withdrawnfrom a lumen within the PAC to be positioned at or adjacent the targetsite 50. The PAC may be removed allowing the guide wire (GW) to remainpositioned therein. The guide wire (GW) may remain located within thevasculature between the access location and the target site to guideother catheters in and out to the target site 60. Notably different fromstep (7) is that the instant delivery system with sensor 200 areadvanced over the guide wire (GW) to the target site.

The delivery system 200 allows for contrast dye to be injected therefromto allow for a real-time imaging (fluoroscopy imaging) of the locationof the delivery system 200 and implant 101 or sensor relative to theanatomy of the patient 70. This allows for the injection of contrast dyeto be performed while the implant 101 is actually near the target site.Further, the radio-opaque markings 205 provide imaging cues to allow themedical practitioner to view and confirm exactly where the deliverysystem 200 and implant 101 are positioned and adjusted relative to theactual target site or other benchmark locations within the anatomy withlive fluoroscopic imaging (steps 80 and 90). This method does notrequire the medical practitioner to compare the relative position of acatheter viewed in the fluoroscopic image with a static angiogram imageacquired when contrast dye was introduced by the PAC moments ago. Thisstep reduces the guess work or estimating of sizes and locations usingthe static image of the angiogram in the estimation of placing thesensor or implant at the target site in the anatomy.

These steps do not require the use of an anatomic reference marker likeribs, spine, or other implants to estimate where the implant 101 may bepositioned or adjusted relative to the target site. This processimproves accuracy and reduces the risk of releasing the implant orsensor in an incorrect location (which could be a safety problem). Thismethod may also benefit when the distal anchor and/or proximal anchorinclude shapes as disclosed by U.S. patent application Ser. No.15/958,613 wherein at least one anchor includes an elongated and angledorientation relative to the implant 101 or the at least one anchor mayinclude a clover-shaped structure. This real-time angiography feature,and the configuration of the anchor's relative to the implant 101 mayallow a medical practitioner to confidently move and adjust the implant101 to the best available location in the anatomy prior to itsplacement. Once the implant is positioned at the target site 80 andadjusted in the best location 90, the implant 101 or sensor may bedeployed 100. The implant 101 may be deployed by the medicalprofessional by pulling the release wires 212 thereby retracting therelease wires 212 from the distal anchor and the proximal anchor toallow the anchors to expand and anchor the implant in place within thetarget site.

The inner sheath 202 may be removed from or partially retracted relativeto the outer sheath 204 and the anatomy of the body 110. Optionally, theguide wire (GW) may also be removed, it may remain in place, or may bepartially removed to provide some stability for the outer sheath 204. Acalibration of the implant 101 may be performed 120. Here, a port 230positioned along a proximal portion (outside the body) is connected to apressure transducer, so that is it fluidically coupled to thebloodstream, at the distal portion of the second sheath 204. Thepressure in the blood vessel is communicated to the port 230 andpressure transducer to provide an accurate reference pressuremeasurement. Notably, a second catheter is not needed (as is required inthe FIG. 1 method). The calibration may be performed by comparing apressure measurement reading taken by the pressure transducer with apressure measurement reading taken by the implant 101 deployed at thetarget site. The pressure measurement reading taken by the implant 101may be wirelessly communicated to a receiver or reader device. Oneexample of a reader device is disclosed by U.S. Pat. No. 8,493,187 andits related patents. The deployed implant 101 may be adjusted bymathematically changing calibration coefficients or by using a lookuptable and programming or adjusting the reader device or implant 101. Theouter sheath 204 may then be removed from the anatomy 130 and the accesslocation may be closed 140.

FIG. 4 illustrates another embodiment and assumes the use of a differenttype of delivery system catheter than the type described in FIG. 1 or 3.This catheter includes a two-sheath concept as in FIG. 2, but alsoincludes the balloon member 220 positioned along a distal portion of theinner sheath 202. This method reduces the need for utilizing a PAC toposition the guide wire at the target site of steps (2) and (3) or steps20 and 30 or to otherwise carry out the procedure.

Step 10′ is comparable to step (1) of FIG. 1 and step 10 of FIG. 3.However, after venous access is established at the access location alongthe patient's anatomy (10′). The distal end of a delivery system 200with balloon member 220 and implant 101 is then inserted at the accesslocation (20′). The balloon may be inflated along a distal portion ordistal top of the delivery system 200, preferably along the inner sheath202 within the vascularity of the patient (30′). In this embodiment,there is no need for a guide wire (GW).

Steps 40′, 50′, and 60′, are similar to steps 70, 80, and 80 of FIG. 3.The delivery system 200 allows for contrast dye to be injected therefromto allow for a real-time imaging (fluoroscopy imaging) of the locationof the delivery system 200 and implant 101 or sensor relative to theanatomy of the patient 40′. This allows for the injection of contrastdye to be performed while the implant 101 is actually near the targetsite. Further, the radio-opaque markings 205 provide imaging cues toallow the medical practitioner to view and confirm exactly where thedelivery system 200 and implant 101 are positioned and adjusted relativeto the actual target site or other benchmark locations within theanatomy with live fluoroscopic imaging (steps 50′ and 60′). Theremaining steps 70′-110′ are comparable to steps 100-140 of FIG. 3.

Once the implant is positioned at the target site 50′ and adjusted inthe best location 60′, the implant 101 or sensor may be deployed 70′.The implant 101 may be deployed by the medical professional by pullingthe release wires 212 thereby retracting the release wires 212 from thedistal anchor and the proximal anchor to allow the anchors to expand andanchor the implant in place within the target site.

The inner sheath 202 may be removed from or partially retracted relativeto the outer sheath 204 and the anatomy of the body 80′. A calibrationof the implant 101 may be performed 90′. The outer sheath 204 may thenbe removed from the anatomy 100′ and the access location may be closed110′.

FIG. 5 illustrates another embodiment and assumes the use of a differenttype of delivery system catheter than the type described in FIGS. 1, 3,and 4. Here, this delivery system 200 includes a two-sheath concept asin FIG. 2, but instead of the pressure transducer and the balloon member220, a reference sensor 210 may be positioned along a distal portion ofthe outer sheath 204. Steps 10″-140″ are otherwise comparable to steps10-140 of FIG. 3. FIG. 2 illustrates use of the reference sensor 210(separate from the implant 101) that is attached along a distal portionof the outer sheath 204. The reference sensor 210 may be powered by abattery and operate wirelessly to communicate pressure data to anoutside receiver. Optionally, the reference sensor 210 may be connectedto circuitry at the proximal end of the delivery system 200 by contactwires. In this embodiment, the reference sensor 210 is utilized in lieuof the pressure transducer and associated fluid port 230 of the outersheath 204 (of FIG. 3) is not needed to perform the calibration step.Calibration step 120″ may thus be performed by the reference sensor 210that is configured to wirelessly communicate information to a receiveror reader device. This disclosure also contemplates an embodiment of thedelivery system 200 that includes the balloon member 220 as well as thereference sensor 210 in which the featured steps of the self-placementof the delivery system 200 with balloon member 200 of FIG. 4 may becombined with the reference sensor 210 based calibration of FIG. 5.

Further, FIG. 6A illustrates an implant 101 from FIG. 22 of commonlyowned U.S. Pat. No. 10,206,592 in which distal and proximal anchors 103,102 are positioned in an expanded configuration within the vasculatureof a patient's anatomy. The anchors are disclosed to extend fromopposing ends of the implant 101 and are attached to the implant 101 atattachment portions 122. FIG. 6A illustrates the implant 101 includes aninner facing surface 132 configured to face inwardly of the vasculatureand an opposite outer facing surface 142 configured to abut against theinner wall of the anatomy. FIG. 6B is a cross sectional view of theimplant 101 according to embodiments of the instant application thatillustrates a novel way to configure the attachment portions 122.

The markers 205, discussed above, may be radio opaque to assist medicalpractitioners to identify a location of a device during fluoroscopy(i.e., x-ray imaging). The markers may be made from radio-opaquechemical compounds which can be added to polymers, ceramics, plastics,or other materials for molding into various shapes. There also existsradio-opaque coatings or inks that can be applied to surfaces. A commonproduct for use in catheters is radio-opaque tubing, such as supplied byZeus, Polyzen, or Fluortek Corporation.

FIGS. 7A-7E illustrate an embodiment of the instant disclosure thatidentifies an improvement over known embodiments of implants that areconfigured to include markers thereon. In an embodiment of thedisclosure, the markers may include a cylindrical shape length of amarker or tube 998 having radio-opaque material thereon. The marker 998may be a tube cut into a cylinder shape of desired length and attachedto a portion of the anchor by a heatshrink, adhesive, or other processsuch as friction fit.

This disclosure illustrates an improved way to attach and configuremarkers to assist in fluoroscopic imaging to an implant 101. In anembodiment, a plurality of through holes may be drilled through portionsof the implant 101. There may be any number of through holes but in thedisclosed embodiment, four holes are provided to include four attachmentpoints 122 to the implant for use with the distal and proximal anchors103, 102. The through holes may be counter-bored having two overlappingholes of different diameters. A first hole 124 being a through holehaving a first size, and a second hole 126 only extending partiallythrough the implant body and having a second size. The first hole 124may be concentric relative to the second hole 126. In this embodiment,the first size may be smaller than the second size thereby creating ashoulder or stop between the first hole 124 and second hole 126. In FIG.7A, a terminal end 999 of anchor wire 102 or 103 may be threaded throughthe first and second holes 124, 126, with the terminal end exitingthrough the large sized second hole 126. FIG. 7B illustrates the marker998 as a tube attached along the anchor wire adjacent to a terminal endof the anchor. The marker 998 may be a cylindrical shaped radio opaquemarker tube 998 that is slid over the free end of the anchor. The marker998 may sit freely along the wire or may be adhered, heat shrunk,crimping, or friction fit thereon. Note that the marker may be any shapeand is not limited to being cylindrical.

FIG. 7C illustrates an enlarged end 997 positioned on the terminal end999 of the wire of the anchor 102/103. The enlarged end 997 and marker998 are configured to be positioned within the larger sized second hole126 while the remaining portion of the anchor extend through the smallersized first hole 124. As such, at least the enlarged end 997 may abutagainst the shoulder and may not exit through the small sized first hole124. The enlarged end 997 may be formed by: heating the end to form aball; using a laser; stamping; “coining” or otherwise compressing theend to flatten it; bending the end to form a coil shape, or otherwiseenlarging it by means known to those skilled in the art. FIG. 7Dillustrates the assembly having larger materials fit snugly into thelarge size second hole 126. The enlarged end 997 ensures that the wirecannot exit the first hole 124, increasing system safety andreliability. In FIG. 7E, the remaining space in the holes 124, 126 maybe filled with a filler material 996, typically adhesive, pottingmaterial, epoxy or other filler material that may be safe for humanimplantation. As implant 101 may be made of a glass or ceramic material,the concentric through hole configuration is not known to be used in animplant assembly, method of manufacture, or delivery system. Theembodiments of the marker and implant 101 assembly may include variousalternate designs including: (i) without a marker band 998, but use of aradio opaque filler material 996; (ii) no marker band; (iii) crimp-onmarker band 998 and no enlarged end (the crimp-on holds the wire inplace); (iv) no enlarged end, filler material holds the assembly inplace. Notably, two ends of said wire anchor may be attached to saidimplant body such that said anchor forms a loop and the counter boredhole may be filled with a filler material to prevent translational orrotational movement of said anchor.

FIGS. 8A, 8B, and 8C illustrate the concept of providing symmetrical orasymmetrical radio opaque markings. As can be seen in FIG. 6A, theimplant body, shown in side view, includes an inner facing surface 132configured to face inwardly of the vasculature and an opposite outerfacing surface 142 configured to abut against the inner wall of theanatomy. The inner facing surface 132 may include a sensitive diaphragmdesirable to keep away from a vessel wall and facing towards thebloodstream to be able to accurately sense or measure pressure. FIG. 8Aillustrates markers 998 placed in four corners to allow a fluoroscopeimage to view the implant 101 to include four dots. The hashed outlineof the implant body is for reference only and would likely not bevisible on the fluoroscope image. The plurality of said markers comprisean asymmetric pattern on said implant body, said pattern configured tofacilitate determination of implant orientation when viewed on afluoroscope. Said asymmetric pattern may include three marks positionedalong three corners of a two-dimensional rectangle when viewed on afluoroscope.

By making the dot pattern asymmetrical, as in FIG. 8B, the fluoroscopeimage can identify which surface (inner facing surface 132 or outerfacing surface 142) and relative position of the implant 101 may beviewable. In an embodiment, the asymmetrical pattern includes placingmarkers 998 in three of the four corners. In this way, the medicalpractitioner may easily identify which surface is facing an imagingdevice to allow for precise adjustment and positioning the implant atthe target site in the anatomy. Notably, any type of asymmetrical orsymmetrical configuration is contemplated by this disclosure and is notlimited to the placement or configuration of markers 998 illustrated byFIGS. 8A, 8B, and 8C.

FIG. 2 illustrates various locations to place markers 205 on either orboth the implant 101 and the sheaths 202, 204 of the delivery system200. These locations include but are not limited to the distal tip 201;distal end of the second sheath 202; a set of ruled stripes along firstsheath 204 or second sheath 202. The ruled stripes could be evenlyspaced or unevenly spaced. These marker arrangements can help serve as aruler to judge distances, positions, and adjustments during placement ofthe implant by viewing live images on the fluoroscope.

FIG. 9 illustrates an embodiment of the delivery system 200 in crosssection having the implant 101 mounted thereon as viewed towards thedistal end. The inner sheath 202 may include a plurality of lumensaligned along its length. In one embodiment, the inner sheath 202includes general triangle shape cross section with a plurality of outerlumens 900, 901, and 902 spaced from one another at about 0°, 120°, and240° and extruded along its length. A center lumen 903 may be positionedalong centrally from the outer lumens. Any number of lumens, includingone, two, three, four, five, six, seven, or more are contemplated bythis disclosure. Each of the plurality of lumens may extend the entirelength of inner sheath 202. Additionally, one or more of the lumens mayinclude slots or flattened portions to assist with attachment of theimplant 101 thereto.

The hashed line represents an outer perimeter of the outer sheath 204.Part of the inner sheath 202 may be contained inside the outer sheath204 (not shown except as hashed line), and part of the inner sheath 202may extend outside the outer sheath 204 as illustrated by FIG. 2. Thelarge rectangle 906 represents a body of the implant 101. The body 906may rest on a flattened region (as a portion of lumen 902 may be cut orflattened out) on the portion of inner sheath 202 that extends outsideof outer sheath 204. The center lumen 903 may be larger than the outerlumens 900, 901, 902 and may be configured to support the guide wire(GW) as described above.

Lumens 900 and 901, positioned along the underside of the inner sheath202 may be to support the release wires 212. In one embodiment, theanchors 102, 103 may be folded down in a collapsed configuration andpositioned partially around or tucked under the bottom of the innersheath 202. The release wires 212 may be made of nitinol, stainlesssteel, or another extrudable material, and may be contained in lumens900 and 901. The release wires 212 may be threaded through various slots215 as identified in FIG. 2 to hold the anchors 102, 103 in thecollapsed configuration. In an embodiment, the release wires 212 may bepulled proximally from the proximal end of the delivery system (wherethere may be a handle). As ends of the release wires 212 move past eachcollapsed anchor 102, 103, the anchor is released and deploys to itsunfolded or expanded shape. The anchors may each deploy one at a time orsimultaneously.

Alternatively, the delivery system 200 may include a single continuousrelease wire 212 that aligns through a first lumen (e.g., 900), tiesdown anchors 102, 103 along a first side of the implant 101 and loopsaround the distal portion to tie down opposing sides of the anchors 102,103 on the other side through a second lumen (e.g., 901). Here, themedical practitioner would pull just one end of that release wire 212 torelease the anchors 102, 103 from the delivery system 200.

In one embodiment, lumen 902 is not used. In another embodiment, lumen902 could be used for a third release wire that could support along atop side of implant body 906 to provide more stability and tie-downsecurity. In another embodiment, lumen 902 could be used as a fluidcolumn to connect to the pressure transducer and fluid port 230 locatedoutside the body. Notably, the pressure transducer and fluid port 230may be positioned along the inner sheath 202 or the outer sheath 204 butby using the inner sheath 202, a medical practitioner may be able tomeasure a pressure reading during the time the inner sheath 202 iswithin the body. In another embodiment, lumen 902 may be used to injectfluids such as contrast dye or drugs. Alternatively, the outer sheath204 can be used to inject fluids such as contrast dye or drugs.

In another embodiment as illustrated by FIG. 10, provided is an implantretrieval system 300 for removing an implanted device 100 from a humanbody. The implanted device having at least one portion (i.e., anchors102, 103) that may be collapsible and wherein the first sheath 202 andsecond sheath 204 each extending from a proximal end and at least saidfirst sheath extends to a distal end of the retrieval system 300. Thefirst sheath 202 is positioned at least partially within said secondsheath 204 wherein said first sheath 202 includes a linkage member 310is configured to mechanically couple to a portion of said implanteddevice 101. The first sheath 202 and said second sheath 204 may berotatably and translatable with respect to one another and saidcollapsible anchors 102, 103 of said implanted may be configured toreturn to a collapsed state when said first sheath 202 or said linkagemember 310 retracts said implant 101 proximally into said second sheath204.

The second sheath 204 of the retrieval system 300 may be configured tohold said collapsible portion 102, 103 of said implant 101 in saidcollapsed state while said system and said implant are withdrawn fromsaid body. The retraction of said implant 101 may be accomplished byapplying distally directed force to said second sheath 204 whileapplying a proximally directed force to said first sheath 202 or saidlinkage member 310 while said first sheath 202 is mechanically coupledto said implanted device 101. The retrieval system 300 may also includea balloon member 220 wherein said balloon member 220 may be configuredto facilitate reducing blood flow during mechanical capture andretraction of said implanted device. The balloon member 220 may beconfigured to follow blood flow to initially guide said system to thelocation of said implanted device prior to retrieval.

The second sheath 204 (of either the retrieval system 300 or thedelivery system 200) may be further configured to remain in place toallow exchanging the first sheath 202 for other catheter devices whereinsaid catheter device includes at least one of: a camera, a pressuresensing catheter, a stent placement device, a valve placement device, amicrophone, an ablation device, a balloon device, a Swan Ganz catheter,an electrical stimulation device, an ultrasound device, a drug deliverydevice, a catheter for gripping implanted devices (linkage member 310),a catheter for readjusting the position of implanted devices, a catheterfor removing implanted devices. The second sheath may also be configuredto contain a plurality of sheaths in addition to said first sheath. Thesystem 300 may also be configured to detach said implanted device 101from surrounding tissue while said first sheath is mechanically coupledto said device wherein said detachment of said device from saidsurrounding tissue comprises cutting off a portion of said device andleaving said portion attached to said tissue as said device isretracted. Alternatively, the detachment of the implanted device fromsaid surrounding tissue may include cutting off a portion of saidsurrounding tissue and leaving said portion attached to said device assaid device is retracted. The detachment may be accomplished by one of:mechanical cutting, tissue ablation, local application of heat, localapplication of laser energy, local application of radio frequency (RF)energy, local application of ultrasonic energy, local application ofvibrational energy.

Having described preferred embodiments of new and improved deliverysystem and implant configurations and methods, it is believed that othermodifications, variations and changes will be suggested to those skilledin the art in view of the teachings set forth herein. It is therefore tobe understood that all such variations, modifications and changes arebelieved to fall within the scope of the present application.

Although the embodiments of the present teachings have been illustratedin the accompanying drawings and described in the foregoing detaileddescription, it is to be understood that the present teachings are notto be limited to just the embodiments disclosed, but that the presentteachings described herein are capable of numerous rearrangements,modifications and substitutions without departing from the scope of theclaims hereafter. The claims as follows are intended to include allmodifications and alterations insofar as they come within the scope ofthe claims or the equivalent thereof.

Having thus described the application, I claim:
 1. An implant deliverysystem comprising: an implant; a first sheath and a second sheath eachextending from a proximal end of said implant delivery system, whereinat least said first sheath extends to a distal end of said implantdelivery system, wherein said first sheath is positioned at leastpartially within said second sheath, the first sheath is translatablerelative to said second sheath; wherein said implant is connected to anexterior surface of said first sheath, and wherein said first sheath andsaid second sheath are movable with respect to one another to deploysaid implant to a target site in an anatomy; and further wherein saiddelivery system is configured to be partially inserted into a livingbody such that said proximal end remains external to said body and saiddistal end is internal to said body.
 2. The implant delivery system ofclaim 1, wherein said delivery system is configured to be partiallyinserted into a blood vessel of a human body such that said proximal endremains external to said body and said distal end is internal to saidbody.
 3. The implant delivery system of claim 1, further comprising atleast one fluid port positioned along a proximal end of said firstsheath or second sheath, said fluid port fluidly coupled to at least onelumen extending down the length of said first sheath or second sheath toallow fluid flow through said lumen.
 4. The implant delivery system ofclaim 3, wherein said fluid is injected through said port and includesone of: a drug; a fluid used to enhance anatomical imaging; fluoroscopiccontrast dye; barium; a radioactive material; blood; plasma; salinesolution; a blood component; a particle suspension; a nano-device; and ananomaterial.
 5. The implant delivery system of claim 3, wherein said atleast one fluid port is further configured to operatively couple to adevice located outside of said body.
 6. The implant delivery system ofclaim 5, wherein said device is a pressure transducer, configured tomeasure a fluid pressure at the distal end of said first or said secondsheath.
 7. The implant delivery system of claim 6, wherein saidmeasurement of fluid pressure at the distal end of said first or secondsheath is used to calibrate or assess the accuracy of said implant. 8.The implant delivery system of claim 1, further comprising at least onemarker configured to be visible with a fluoroscope.
 9. The implantdelivery system of claim 8, wherein said marker include a radio opaquematerial positioned on at least one of: a distal tip of said firstsheath; the distal portion of said second sheath; a portion of saidimplant; and as a plurality of markings spaced along a portion of saidfirst or said second sheath.
 10. The implant delivery system of claim 8,wherein said marker is attached to at least one anchor on the implant.11. The implant delivery system of claim 8, wherein a plurality ofmarkers are positioned along said implant in an asymmetric pattern, saidpattern is configured to facilitate determination of implant orientationwhen viewed on a fluoroscope.
 12. The implant delivery system of claim11 wherein said asymmetric pattern comprises markers at three of thefour corners of a two-dimensional rectangle when viewed normal to theplane of said rectangle on a fluoroscope.
 13. The implant deliverysystem of claim 1, wherein: said second sheath is configured to allowinsertion of a catheter device configured to selectively attach to saidimplant and move the implant proximally when retracted; wherein at leastone anchor of said implant is collapsible; and wherein said anchor ofsaid implant is configured to be placed in a collapsed state when saidcatheter device moves the implant proximally into said second sheath.14. The implant delivery system of claim 1, wherein said second sheathis further configured to allow said first sheath to be retracted intosaid second sheath while said implant is still connected to said firstsheath, and further configured to cover said first sheath and saidimplant while said delivery system is retracted and withdrawn from saidbody.
 15. The implant delivery system of claim 1, wherein said firstsheath is configured with a distal tip made of a soft material tominimize vessel trauma during use, wherein said distal tip has adurometer softer than Shore 40A.
 16. The implant delivery system ofclaim 1, wherein said implant further comprises a rigid housing, and atleast one collapsible implant anchor, said at least one anchor beingattached to said housing.
 17. The implant delivery system of claim 16,wherein said anchor is comprised of at least one wire that passesthrough at least one hole that extends through the thickness of saidhousing; and an enlarged portion of the wire is placed along said wireto retain the wire within the hole; and wherein said hole iscounter-bored, said counter-bored hole comprising a first size hole anda second size hole, wherein the first size is smaller than the secondsize, wherein the second hole extends only partially through saidhousing, and further wherein said enlarged portion is configured to fitinto said second hole.
 18. The implant delivery system of claim 17,wherein said implant includes a marker configured to be at leastpartially visible under fluoroscopic imaging.
 19. The implant deliverysystem of claim 18, wherein a plurality of said markers are spaced atknown intervals along said anchor wire to facilitate distance estimationduring angiographic imaging; and wherein said marker is located on theanchor wire near a point where said anchor wire attaches to saidhousing.
 20. A method for implanting an implant device in thevasculature of a human body, said method comprising the steps of:establishing access to the vasculature at an access location along thepatient's anatomy; inserting a first catheter configured to translatefrom the access location to a target site within the vasculature;placing a guide wire between said access point to said target location;removing said first catheter while leaving said guide wire in place;inserting a delivery system over said guide wire, said delivery systemcomprising a first sheath and a second sheath each extending from aproximal end of said implant delivery system, wherein at least saidfirst sheath extends to a distal end of said implant delivery system andwherein said first sheath is positioned at least partially within saidsecond sheath, and includes an implant attached to said first sheath,wherein said first sheath or second sheath is configured to allow theinjection of contrast dye for angiographic imaging; advancing saiddelivery system to said target site while using angiographic imaging toposition said implant at said target site; deploying said implant fromsaid delivery system at said target site; withdrawing said secondcatheter and said guidewire from said body while said medical deviceremains at said target location.
 21. The method of claim 20, whereinsaid delivery system includes a port configured to remain outside ofsaid vasculature and to fluidically couple a portion of said firstsheath or second sheath that is inside said vasculature to a device thatis outside of said vasculature, said method further comprising the stepsof: connecting said port to a pressure measurement device; measuringpressure at said inside portion of said first sheath or second sheathusing said pressure measurement device; measuring pressure at saidinside portion with said implant; comparing said measurement from saidpressure measurement device to a measurement made by said implant. 22.The method of claim 21, further comprising calibrating said implant. 23.The method of claim 20, wherein said implant is connected to an exteriorsurface of said first sheath and positioned near a distal end of saidsecond sheath, and wherein said first sheath and said second sheath aremovable with respect to one another to deploy said implant to the targetsite.
 24. A method for implanting an implant in a vasculature of a body,said method comprising the steps of: establishing access to thevasculature at an access location; inserting a catheter device into saidvasculature at said access location, said catheter device fitted withsaid implant and configured to advance to a target site; advancing saidcatheter device to said target site; deploying said implant from saidcatheter device at said target site; withdrawing said catheter devicefrom said body while said implant remains at said target site.
 25. Themethod of claim 24, wherein said catheter device is configured to injectcontrast dye into said vasculature to facilitate angiographic imaging,said method further comprising the step of advancing said catheter tosaid target location while using angiographic imaging.
 26. The method ofclaim 25, wherein said catheter device is configured to fluidicallycouple a portion of said catheter device inside said vasculature to aportion of said catheter device that is outside of said vasculature,said method further comprising the steps of: connecting said portion ofsaid catheter device that is outside of said vasculature to a pressuremeasurement device; before withdrawing said catheter device from saidbody, measuring pressure at said portion of said catheter device insidesaid vasculature using said pressure measurement device; measuringpressure using said implant; comparing said measurement from saidpressure measurement device to a measurement made by said implant. 27.The method of claim 24, wherein said catheter device comprises a firstsheath and a second sheath each extending from a proximal end of saidcatheter device, wherein at least said first sheath extends to a distalend of said implant delivery system, wherein said first sheath ispositioned at least partially within said second sheath; wherein saidimplant is connected to an exterior surface of said first sheath andpositioned near a distal end of said second sheath, and wherein saidfirst sheath and said second sheath are movable with respect to oneanother to deploy said implant to a desired target location.
 28. Amethod for attaching a wire anchor to a rigid implant body, comprisingthe steps of: providing at least one hole that extends through animplant housing; passing an anchor wire through said hole; enlarging atleast one portion along said wire to prevent said enlarged portion frompassing through said hole.
 29. The method of claim 28 further comprisingcounter-boring said hole to create a large portion and a small portion.30. The method of claim 29 further comprising the step of placing saidenlarged portion of said wire into said large portion of said hole. 31.The method of claim 30 further comprising the step of placing at leastone preformed fluoroscopic marker over said anchor wire prior toenlarging said dimension of said terminal end.